Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy

NCT07318285 | Not Yet Recruiting

• 1 other identifier: 0220-25-HMO
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to find out whether a small amount of lidocaine (a common local anesthetic) can reduce pain during office hysteroscopy - a procedure used to look inside the uterus. The study will compare lidocaine to saline (salt water) to see which one helps more with pain relief. Participants will:

1. 1.Receive either lidocaine or saline gently applied inside the cervix right before the procedure
2. 2.Undergo the hysteroscopy as planned
3. 3.Be asked to rate their pain and satisfaction after the procedure

Conditions

Hysteroscopy / Methods; Lidocaine Infusion; Placebo - Control

Outcome Measures

Primary Outcomes (2)

• Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS)

  Pain experienced during the procedure, evaluated using a Visual Analog Scale (VAS). The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.

  Immediately during the hysteroscopy procedure

• Number of Participants with Successful Access to the Uterine Cavity

  The number of participants for whom hysteroscopy successfully reached the uterine cavity, without the need to stop or repeat the procedure. This binary outcome (Yes/No) will be assessed by the performing physician during the procedure. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.

  During the hysteroscopy procedure

Secondary Outcomes (5)

• Visual Analog Scale (VAS) Pain Score 5 Minutes After the Procedure

  5 minutes after completion of the hysteroscopy procedure

• Change in Visual Analog Scale (VAS) Pain Score from Baseline to During the Procedure

  Changes of VAS score of pain from baseline (before procedure) and at 5 minutes of during procedure.

• Completed procedure

  During the hysteroscopy procedure

• Patient satisfaction

  Immediately after the procedure

• Adverse effect

  During and up to 10 minutes after the procedure

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Participants in this arm will receive 5 mL of normal saline infused through the internal cervical os immediately before office hysteroscopy.

Other: Saline (0.9% NaCl)

Lidocaine Group

EXPERIMENTAL

Participants in this arm will receive 5 mL of 2% lidocaine infused through the internal cervical os immediately before office hysteroscopy.

Drug: Lidocaine %2 ampoule

Interventions

Lidocaine %2 ampoule DRUG

A 5 mL dose of 2% lidocaine solution will be infused slowly through the internal os using the hysteroscope before the start of uterine cavity distension.

Lidocaine Group

Saline (0.9% NaCl) OTHER

A 5 mL dose of sterile normal saline will be infused slowly through the internal os using the same technique as in the intervention arm, immediately before cavity distension.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Referred for outpatient diagnostic or operative (see-and-treat) hysteroscopy
• Able and willing to provide written informed consent

You may not qualify if:

• Pregnancy
• Active pelvic inflammatory disease or cervicitis
• Inability to consent
• Anti-psychotic drugs usage
• Previews cervical surgery (i.e., conization).
• Any contraindication for office hysteroscopy- cervical malignancy, profuse uterine bleeding, invisible external os, recent uterine perforation.
• Known allergy or hypersensitivity to Lidocaine

Sponsors & Collaborators

• YAARA TABIB: lead

Related Publications (3)

• Barel O, Preuss E, Stolovitch N, Weinberg S, Barzilay E, Pansky M. Addition of Lidocaine to the Distension Medium in Hysteroscopy Decreases Pain during the Procedure-A Randomized Double-blind, Placebo-controlled Trial. J Minim Invasive Gynecol. 2021 Apr;28(4):865-871. doi: 10.1016/j.jmig.2020.08.003. Epub 2020 Aug 14.

  PMID: 32798723 BACKGROUND

• Shankar M, Davidson A, Taub N, Habiba M. Randomised comparison of distension media for outpatient hysteroscopy. BJOG. 2004 Jan;111(1):57-62. doi: 10.1046/j.1471-0528.2003.00004.x.

  PMID: 14687053 BACKGROUND

• Sagiv R, Sadan O, Boaz M, Dishi M, Schechter E, Golan A. A new approach to office hysteroscopy compared with traditional hysteroscopy: a randomized controlled trial. Obstet Gynecol. 2006 Aug;108(2):387-92. doi: 10.1097/01.AOG.0000227750.93984.06.

  PMID: 16880310 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Obstetrics and Gynecology Research Unit, Hadassah Medical Center

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available starting 6 months after publication and for a period of 5 years
• Access Criteria: Access will be granted to researchers with approved scientific proposals. Requests will be reviewed by the principal investigator and institutional review board. Data will be shared through secure institutional channels.